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临床试验/NCT06869837
NCT06869837已完成不适用

Effects of External Oblique Intercostal Plane Block Applied in Laparoscopic Cholecystectomy Surgery on Intraoperative Opioid ConsumptionDetermined by ANI (Analgesia Nociceptive Index) and Postoperative Analgesia Quality Guide; A Randomized Controlled Trial

Samsun University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Intraoperative opioid consumption

研究概览

简要总结

The aim of the study was to evaluate the response of regional anesthesia to remifentanyl consumption in patients undergoing laparoscopic cholecystectomy surgery.

详细描述

Routine anesthesia and analgesia protocol will be applied to all participants. The study aims to evaluate the remifentanyl consumption of the participants by dividing them into two groups as those with and without block and then performing their monitoring (pulse, mean arterial pressure with noninvasive measurement, oxygen saturation, Analgesia Nociception Index, Bispectral index). Remifentanil level will be adjusted according to the ANI value. The target is to keep the ANI between 50-70.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participants who will undergo elective laparoscopic cholecystectomy surgery,
  • •Age 18-70,
  • •ASA I-II physical status,
  • •Body mass index (BMI) < 35 kg/m²,
  • •Participants who have written consent to participate in the study

排除标准

  • •Participants with routine analgesic consumption,
  • •Those with coagulopathy,
  • •Those with a history of local anesthetic allergy,
  • •Those with cardiac arrhythmia and pacemaker,
  • •ASA III and above, Those with dementia

研究组 & 干预措施

Group EOİPB

Active Comparator

Bilateral External oblique intercostal plane block will be applied 45 minutes before surgery.

干预措施: Group EOİPB (Other)

Group Control

No Intervention

No intervention will be made in this group.

结局指标

主要结局

Intraoperative opioid consumption

时间窗: During surgery

Total amount of remifentanil consumed during cholecystectomy surgery

次要结局

  • Numeric rating scale for postoperative pain intensity(up to 24 hours (Will be evaluated at 1, 3, 6, 9, 12, 18, 24 hours))
  • Quality of Recovery - 15 score(Postoperative 24th hour)
  • Fentanyl consumption at 30 minutes after arrival in the PACU(post anesthesia care unit)(30 minutes)

研究者

发起方
Samsun University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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